Law Updates
Subject: Ministry of Chemicals and Fertilizers Issues Revised NPPA Drug Prices
The National Pharmaceutical Pricing Authority has issued a new price update under the Drugs Prices Control Order, 2013, acting through the Ministry of Chemicals and Fertilizers. The order fixes new retail prices for specific drug formulations submitted by manufacturers and marketing companies through Form I. These prices are exclusive of GST, which can be added only when it is officially payable.
Manufacturers should calculate pack-wise prices as per paragraph 11 of DPCO 2013 and submit the revised price list in Form V through IPDMS. A copy must also be sent to the State Drug Controller and to dealers. Retailers and dealers are required to show the updated price list in a clearly visible area of their premises, ensuring transparent access for consumers.
The notification also supersedes any previous price orders for the same formulations. Non-compliance will need manufacturers or marketers to return the overcharged amount with interest under DPCO 2013 and the Essential Commodities Act, 1955. The update reinforces pricing discipline and regulatory oversight across the pharmaceutical supply chain.
Subject: CPCB Mandates OCEMS Installation in NCR-Delhi Industries
On 01 October 2025 and 09 October 2025, CPCB issued drafts regarding clear directions for all air-polluting industries operating in NCR-Delhi. These directions mandate installation and connectivity of only verified Online Continuous Emission Monitoring Systems (OCEMS).
The national verification agency, CSIR-NPL (Council of Scientific & Industrial Research – National Physical Laboratory), now runs an OCEMS certification scheme. To date, 21 OCEMS models have received CSIR-NPL verification. Only these certified models are permitted to connect to the CPCB server.
Industries must install these certified OCEMS units before any connectivity approval. Regulatory authorities must ensure compliance for every listed industry in their jurisdiction. A list of certified models appears on the CPCB website and requires periodic checking since the list will update over time.
Use of non-certified OCEMS is strictly prohibited. The move aims to standardize emission monitoring and secure reliable, real-time air quality data across NCR-Delhi. Immediate action by authorities will help enforce regulatory compliance and support cleaner air monitoring across all relevant industries.
Subject: CDSCO Issues Final Classification for Radiology and Radiotherapy Devices
The Central Drugs Standard Control Organization (CDSCO) has officially finalized the risk classification of medical devices used in interventional radiology and radiotherapy under the Medical Devices Rules, 2017. These classifications comply with the draft lists released on January 6, 2025.
The updated lists are included in Appendix A of the respective notifications and give a structured framework for defining regulatory requirements for manufacturing and import.
The CDSCO elucidates that the general intended use given for each device acts only as guidance, manufacturers may describe particular intended uses for their products. The notified classifications are active and may be revised from time to time under the Medical Devices Rules, 2017.
Each device is assigned to Class A, B, C, or D, which determines the applicable regulatory pathway to ensure safety, quality, and compliance for technologies used in radiological and therapeutic procedures.
Subject: Updated ALMM List-I with Verified Solar PV Modules and Manufacturers
The Ministry of New and Renewable Energy (MNRE) has updated the ALMM List-I for solar PV modules under the ALMM Order, 2019. This update ensures only BIS-compliant solar module manufacturers and models are enlisted. The enlistment applies to four categories of solar modules: Category I for utility or grid-scale power plants, Category II for rooftop and solar pumping systems, Category III for other applications, such as off-grid solar lamps and streetlights, and Category IV for small off-grid solar applications under 200 watts peak.
Each module must meet minimum efficiency standards. For crystalline silicon (c-Si) technology, utility-scale modules must achieve 20%, while rooftop modules require 19.5%. Thin-film CdTe modules must meet 18–19% depending on the application. Only models that meet these efficiency thresholds are considered for ALMM enlistment.
The latest revision, Revision-XLIV, updates the previous list dated 13.10.2025. BIS registration validity is mandatory, and any module without active BIS certification is automatically delisted. Each manufacturer and manufacturing unit in the list is assigned a BIS Registration Number. Additional details about certification, validity, and models are available on the BIS website.
This change helps everyone trust the solar market more. Only good-quality solar panels get a place on the list. These panels can work in big power plants, on rooftops, and in small off-grid systems like street lights and pumps. Every panel must follow BIS rules to stay on the ALMM list. If the rules are not followed, the panel name gets removed. This keeps solar products in India safe, strong, and ready to give clean power for a long time.
Subject: MNRE Issues Second Revision of ALMM List-II
The Ministry of New and Renewable Energy (MNRE) has notified the second amendment of the Approved List of Models and Manufacturers (ALMM) List-II for solar PV cells. This amendment follows the previous office memorandums issued in 2019, 2024, and the amendment dated 28 July 2025, which govern the ALMM implementation and enrolment process. The official List-II was published on 31 July 2025, and the latest revision has been released after obtaining clearance from the respective authority.
The revised list includes new entries added on 24 November 2025. A key inclusion is Websol Energy System Limited, registered with a manufacturing capacity of 602 MW per year. Its approval will stay valid from 24 November 2025 to 23 November 2029.
MNRE’s update strengthens the government’s agenda for quality assurance and transparency in solar PV cell manufacturing. By maintaining and reviewing ALMM List-II, the ministry focuses on ensuring that only evaluated and compliant manufacturers are qualified for government-supported solar projects. This measure is expected to guide procurement decisions, uplift industry principles, and support India’s push toward sturdier domestic renewable energy manufacturing.
Subject: FSSAI Mandate for Dairy Vending Safety
The Food Safety and Standards Authority of India (FSSAI) has issued a directive to strengthen safety compliance for dairy units selling milk and milk products through vending machines, kiosks, and similar dispensing systems. To protect consumer health, avoid adulteration, and promote transparency, all dairy manufacturers operating such systems should maintain FSSAI-approved or validated rapid test kits at each vending location. These kits are intended for basic detection of common adulterants in milk and milk products.
Dairy units must also display simple, clear instructions on how to use the rapid test kits. They are required to simplify consumer self-checking either by allowing direct use of the kits at the kiosk or by giving demonstrations through trained staff. All test kits must remain within their validity period and be stored according to manufacturer guidelines to ensure accuracy. Additionally, dairy units must regularly monitor and maintain records of kit usage and test results.
This mandate aims to build consumer trust, ensure product integrity, and support a participatory food safety culture across dairy vending operations.
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